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Results for “randomized controlled trials”

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PubMed2001

Effects of physical activity counseling in primary care: the Activity Counseling Trial: a randomized controlled trial.

CONTEXT: Physical activity is important for health, yet few studies have examined the effectiveness of physical activity patient counseling in primary care. OBJECTIVE: To compare the effects of 2 physical activity counseling interventions with current recommended care and with each other in a primary care setting. DESIGN: The Activity Counseling Trial, a randomized controlled trial with recruitment in 1995-1997, with 24 months of follow-up. SETTING: Eleven primary care facilities affiliated with 3 US clinical research centers. PARTICIPANTS: Volunteer sample of 395 female and 479 male inactive primary care patients aged 35 to 75 years without clinical cardiovascular disease. INTERVENTIONS: Participants were randomly assigned to 1 of 3 groups: advice (n = 292), which included physician advice and written educational materials (recommended care); assistance (n = 293), which included all the components received by the advice group plus interactive mail and behavioral counseling at physician visits; or counseling (n = 289), which included the assistance and advice group components plus regular telephone counseling and behavioral classes. MAIN OUTCOME MEASURES: Cardiorespiratory fitness, measured by maximal oxygen uptake (VO(2)max), and self-reported total physical activity, measured by a 7-day Physical Activity Recall, compared among the 3 groups and analyzed separately for men and women at 24 months. RESULTS: At 24 months, 91.4% of the sample had completed physical activity and 77.6% had completed cardiorespiratory fitness measurements. For women at 24 months, VO(2)max was significantly higher in the assistance group than in the advice group (mean difference, 80.7 mL/min; 99.2% confidence interval [CI], 8.1-153.2 mL/min) and in the counseling group than in the advice group (mean difference, 73.9 mL/min; 99.2% CI, 0.9-147.0 mL/min), with no difference between the counseling and assistance groups and no significant differences in reported total physical activity. For men, there were no significant between-group differences in cardiorespiratory fitness or total physical activity. CONCLUSIONS: Two patient counseling interventions differing in type and number of contacts were equally effective in women in improving cardiorespiratory fitness over 2 years compared with recommended care. In men, neither of the 2 counseling interventions was more effective than recommended care.

Adult↗

PubMed1988

Fine catheter peritoneal cytology for the acute abdomen: a randomized, controlled trial.

A randomized, controlled clinical trial, of sequential design, was undertaken to determine whether fine catheter aspiration cytology of the peritoneal cavity, using the percentage of neutrophils in the sample as the main test marker, reduces errors about urgent laparotomy in patients admitted to a surgical unit with acute abdominal pain. One hundred and forty-four patients with acute abdominal pain were studied. Of these, 26 were excluded because the test was unlikely to be useful and 20 did not consent. Conventional clinical assessment was undertaken and then the subjects were randomly allocated to have a peritoneal cytology test or not. After the test result was made available, the surgeon(s) decided whether to operate or continue conservative treatment. The correct decision was later ascertained by a blinded clinical referee. With the entry of the 98th patient the difference between the groups achieved the 5% significance level. The groups were well-matched in regard to demographic and other variables. The decision about urgent laparotomy was incorrect in only 8.2% of the test patients, compared with 28.6% of the others. It is concluded that fine catheter aspiration cytology of the peritoneal cavity is likely to reduce the numbers of unnecessary or delayed laparotomies when used in most patients admitted with acute abdominal pain.

Abdomen, Acute↗

PubMed2005

Comparison of a biopsychosocial therapy (BT) with a conventional biomedical therapy (MT) of subacute low back pain in the first episode of sick leave: a randomized controlled trial.

This randomized controlled clinical trial compares the effectiveness of a biopsychosocial treatment with a solely conventional biomedical therapy in patients with subacute low back pain using parameters for pain intensity, functional status, depressive dysfunction and work performance. Sixty-four patients with a first-time sick leave between 3 and 12 weeks due to low back pain were randomly assigned to either a conventional biomedical therapy (MT; n=33) group, or a biopsychosocial therapy (BT; n=31) group including a psychotherapeutic module; both in accordance with a standardized 3 weeks inpatient treatment. Pain intensity, functional back capacity, clinical parameters and depressive dysfunction revealed significant improvement in both treatment groups at end of 3 weeks therapy (T1). However, at 6 months (T2), analysis revealed significant better results for nearly all parameters in the BT group that showed further improvement from T1 to T2, whereas the values in the MT group deteriorated from T1 back to the baseline values. During the 2-year period after therapy, 10% in MT and 59% in BT required no further sick leave due to low back pain. The results of the study indicate that a psychotherapeutic element in the treatment of low back pain appears to positively influence pain, functional status and work performance when conducted at an early stage of chronification and helps in the achievement of a better outcome.

Acute Disease↗

PubMed2006

A thermoplastic mandibular advancement device for the management of non-apnoeic snoring: a randomized controlled trial.

This randomized, controlled, crossover trial assessed the effectiveness of an adjustable, thermoplastic, mandibular advancement device (MAD), the TheraSnore, in the management of non-apnoeic snoring. Twenty-three adults who had been referred for a MAD wore the appliance in both a non-advanced and advanced position for 4-6 weeks: the starting position of the MAD was randomized. The outcomes were assessed at baseline and after each phase of MAD wear using questionnaires [(Epworth Sleepiness Scale, snoring history, sleep disturbance, side-effects of the appliance) and a visual analogue scale (daytime sleepiness)]. Eleven subjects had overnight sleep studies at baseline and with the appliance in each position to assess snoring frequency (snores/hour), oxygen saturation, and apnoea hypopnoea index. Supine radiographs were used to examine the oropharyngeal airway at baseline and in response to both appliance positions. In comparison with the non-advanced appliance, the advanced MAD reduced the snores per hour from a median of 398 to 17 (P = 0.002). Sleeping partners reported a marked improvement in their own daytime tiredness (P = 0.002) and sleep disturbance (P = 0.001) when the subject wore the active appliance. The most common side-effect was a dry mouth and 64 per cent of subjects considered the appliance bulky. Radiographic analysis revealed significant vertical opening associated with the appliance and small but significant post-lingual changes with protrusion. The results suggest that the advanced TheraSnore MAD is effective in the treatment of snoring in two out of three non-apnoeic snorers, their sleeping partners derive benefits from this form of treatment, and that complaints of bulkiness and dry mouth may to be related to the inherent vertical opening of the TheraSnore.

Adult↗

PubMed2005

Cognitive-behavioral group therapy as an early intervention for insomnia: a randomized controlled trial.

A randomized controlled design was used with a 1-yr follow-up. The purpose was to compare the effects of two early interventions, a cognitive-behavioral group intervention and a self-help information package, in patients with insomnia. In sum, 165 individuals seeking care for insomnia of 3-12 months duration were randomized to either a group receiving a CBT intervention or a group receiving a self-help information package. At the 1-yr follow-up, 136 participants had completed the entire study. At the 1-yr follow-up, the CBT group intervention was, compared with the control group, effective in producing reductions in dysfunctional beliefs and attitudes about sleep, negative daytime symptoms, as well as vital improvements in sleep (i.e. sleep onset latency, time awake after sleep onset, total sleep time, sleep quality, and sleep efficiency). In comparison with the control group, significantly more participants in the CBT group met criteria at the 1-yr follow-up for clinically meaningful improvements in sleep onset latency, time awake after sleep onset, and sleep efficiency. A CBT group intervention may well be a viable early intervention for patients with insomnia in a wide range of health services.

Adolescent↗

PubMed2004

Both resistance and agility training increase cortical bone density in 75- to 85-year-old women with low bone mass: a 6-month randomized controlled trial.

A randomized, controlled, single-blinded 25-wk prospective study was conducted to compare the effects of group-based resistance and agility training on bone, as measured by both dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT), in older women with low bone mass. Ninety-eight community-dwelling women aged 75-85 yr were randomized to one of three experimental groups: resistance training (n = 32), agility training (n = 34), or stretching (sham exercise) (n = 32). Total hip, femoral neck, and trochanteric bone mineral density (BMD) were measured by DXA. Peripheral QCT measurements were performed at the tibia and radius. The pQCT outcome measures at the shaft regions were cortical bone content, cortical bone cross-sectional area, cortical bone density, and density-weighted polar section modulus (SSI). The pQCT outcome measures at the distal sites were total bone content, total bone cross-sectional area, and total bone density. At trial completion, the agility training group significantly increased cortical bone density by 0.5 +/- 0.2% (SE) at the tibial shaft compared with a 0.4 +/- 0.3% loss in the stretching group. The resistance training group significantly increased cortical bone density (1.4 +/- 0.6%) at the radial shaft compared, with a 0.4 +/- 0.5% loss in the agility training group. No significant between-group differences were observed in the other bone outcome measures (by DXA or pQCT). Future research is needed to determine the mechanism(s) responsible for the observed adaptation of the cortical bone to mechanical loading.

Absorptiometry, Photon↗

PubMed2006

Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity.

OBJECTIVES: To reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting. DESIGN: Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey. SETTING: Twenty nine general practices, Melbourne, Australia. PARTICIPANTS: (1) BMI survey: 2112 children visiting their general practitioner (GP) April-December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score <3.0) children aged 5 years 0 months-9 years 11 months (82 intervention, 81 control). INTERVENTION: Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials. MAIN OUTCOME MEASURES: Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth. RESULTS: Attrition was 10%. The adjusted mean difference (intervention-control) in BMI was -0.2 kg/m(2) (95% CI: -0.6 to 0.1; P=0.25) at 9 months and -0.0 kg/m(2) (95% CI: -0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms. CONCLUSIONS: This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level.

Body Image↗

PubMed1999

Intermittent clamping of suction drains in total hip replacement reduces postoperative blood loss: a randomized, controlled trial.

A randomized, controlled study of 54 patients (28 patients in the trial and 26 in the control group) who had primary total hip replacement was carried out. The 2 suction drains were clamped intermittently 55 minutes in each hour and released for 5 minutes in each hour for 6 hours postoperatively in the trial group. Free drainage was allowed in the control group. The difference in calculated total blood loss was significantly less in the trial group than in the control group (P < .05). Patients in the trial group received 13 fewer blood transfusions than the control group. No difference in wound drainage and wound healing was noted. Using ultrasound, it was also shown that the technique did not lead to hematoma formation.

Aged↗

PubMed2005

The use of a fine-gauge needle to reduce pain in open carpal tunnel decompression: a randomized controlled trial.

This randomized controlled study on 86 patients compared the level of pain experienced by patients on instillation of local anaesthetic into the palm with a 23-gauge and a 27-gauge (dental) needle in open carpal tunnel decompression. Patients were asked to score the amount of pain they experienced during the injection of the local anaesthetic and their level of anxiety about future injections using a visual analogue scale (VAS) and a four-point verbal response scale (VRS). The mean pain and anxiety scores on the VAS were significantly lower in the dental needle group. There was significant correlation between the pain and anxiety VAS scores. When infiltrating local anaesthetic into the palm for open carpal tunnel decompression, the use of a fine (dental) needle can reduce the pain on that occasion and the anxiety concerning future injections likely to be experienced by the patient.

Adult↗

PubMed2004

Combination estrogen-progestin contraceptives and body weight: systematic review of randomized controlled trials.

OBJECTIVE: Many women and clinicians believe that combination estrogen-progestin contraceptive use can lead to weight gain. This concern can deter women from starting hormonal contraception or lead to premature quitting. This review evaluated the association between combination contraceptive use and change in body weight. DATA SOURCES: The computerized databases CENTRAL, MEDLINE, EMBASE, Popline, and LILACS (from their inception to 2002) were used to conduct this review. Known investigators and manufacturers were contacted for information about other trials not discovered in the database search. METHODS OF STUDY SELECTION: All English-language, randomized controlled trials measuring weight change that were at least 3 treatment cycles in duration and that compared a combination contraceptive to a placebo or to a combination contraceptive that differed in drug, dosage, regimen, or study length were eligible for inclusion. Of the 570 reports of randomized controlled trials of eligible interventions that were identified, 42 trials were included in the systematic review. TABULATION, INTEGRATION, AND RESULTS: Two reviewers independently abstracted data from the eligible trials using a standard form. Depending on the data available, the weighted mean difference using a fixed effect model with 95% confidence intervals was calculated for the mean change in weight between baseline and posttreatment measurements or the Peto odds ratio with 95% confidence intervals was calculated by using the proportion of women who gained or lost more than a specified amount of weight. The 3 placebo-controlled, randomized trials did not find evidence supporting a causal association between combination oral contraceptives or a combination skin patch and weight gain. Most comparisons from the 40 trials that compared 2 or more combination contraceptives showed no substantial difference in weight. In addition, discontinuation of combination contraceptives because of weight gain did not differ between groups when this factor was studied. CONCLUSION: Available evidence is insufficient to determine the effect of combination contraceptives on weight, but no large effect is evident.

Adult↗

PubMed1997

Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group.

BACKGROUND: Cytomegalovirus (CMV) retinitis is a common infection and a major cause of visual loss in patients with the acquired immunodeficiency syndrome (AIDS). OBJECTIVE: To evaluate intravenous cidofovir as a treatment for CMV retinitis. DESIGN: Two-stage, multicenter, phase II/III, randomized, controlled clinical trial. SETTING: Ophthalmology and AIDS services at tertiary care medical centers. PATIENTS: 64 patients with AIDS and previously untreated, small, peripheral CMV retinitis lesions (that is, patients at low risk for loss of visual acuity). INTERVENTION: Patients were randomly assigned to one of three groups: the deferral group, in which treatment was deferred until retinitis progressed; the low-dose cidofovir group, which received cidofovir, 5 mg/kg of body weight once weekly for 2 weeks, then maintenance therapy with cidofovir, 3 mg/kg once every 2 weeks; or the high-dose cidofovir group, which received cidofovir, 5 mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5 mg/kg once every 2 weeks. To minimize nephrotoxicity, cidofovir was administered with hydration and probenecid. MEASUREMENTS: Progression of retinitis, evaluated in a masked manner by a fundus photograph reading center; the amount of retinal area involved by CMV; the loss of visual acuity; and morbidity. RESULTS: Median time to progression was 64 days in the low-dose cidofovir group and 21 days in the deferral group (P = 0.052, log-rank test). The median time to progression was not reached in the high-dose cidofovir group but was 20 days in the deferral group (P = 0.009, log-rank test). Analysis of the rates of increase in the retinal area affected by CMV confirmed the data on time to progression. The three groups had similar rates of visual loss. Proteinuria of 2+ or more occurred at rates of 2.6 per person-year in the deferral group, 2.8 per person-year in the low-dose cidofovir group (P > 0.02), and 6.8 per person-year in the high-dose cidofovir group (P = 0.135). No patient developed 4+ proteinuria, but two cidofovir recipients developed persistent elevations of serum creatinine levels at more than 177 mumol/L (2.0 mg/dL). Reactions to probenecid occurred at a rate of 0.70 per person-year. CONCLUSIONS: Intravenous cidofovir, high- or low-dose, effectively slowed the progression of CMV retinitis. Concomitant probenecid and hydration therapy, intermittent dosing, and monitoring for proteinuria seemed to minimize but not eliminate the risk for nephrotoxicity.

AIDS-Related Opportunistic Infections↗

PubMed2006

Rationale, design, and organization of the PeriOperative ISchemic Evaluation (POISE) trial: a randomized controlled trial of metoprolol versus placebo in patients undergoing noncardiac surgery.

BACKGROUND: Noncardiac surgery is associated with significant cardiovascular mortality, morbidity, and cost. Small trials of beta-blockers suggest that they may prevent cardiovascular events in patients undergoing noncardiac surgery, but trial results are inconclusive. We have initiated the POISE trial to definitively establish the effects of beta-blocker therapy in patients undergoing noncardiac surgery. METHODS: The POISE trial is a blinded, randomized, and controlled trial of controlled-release metoprolol versus placebo in 10000 patients at risk for a perioperative cardiovascular event who are undergoing noncardiac surgery. Patients will receive the study drug 2 to 4 hours before surgery and subsequently for 30 days. The primary outcome is a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal cardiac arrest at 30 days. Patients will also be followed for events at 1 year. RESULTS: To date, the POISE trial has recruited >6300 patients in 182 centers in 21 countries. Currently, the patients' mean age is 69 years; 63% are males, 43% have a history of coronary artery disease, 43% have a history of peripheral arterial disease, and 30% have diabetes. Most participants have undergone vascular (42%), intraabdominal (23%), or orthopedic (19%) surgery. CONCLUSIONS: The POISE trial is a large international trial that will provide a reliable assessment of the effects of beta-blocker therapy in patients undergoing noncardiac surgery.

Adrenergic beta-Antagonists↗

PubMed2000

Effect of pre-incision skin infiltration on post-hysterectomy pain--a double-blind randomized controlled trial.

In this double-blind placebo-controlled randomized trial, we compared the analgesic effect of preoperative 0.25% bupivacaine (n = 21) skin infiltration with normal saline (n = 19) in patients undergoing abdominal hysterectomy through a lower midline incision. All patients received postoperative patient-controlled analgesia with morphine and were followed for 72 hours. The main outcome measures were morphine consumption and pain score at rest, and the contribution of different components of pain was also assessed prospectively. No statistically significant differences were found. All except one patient (n = 39) could distinguish the different characteristics of somatic and visceral pain. Visceral pain predominated in the first 48 hours. We concluded that local anaesthetic infiltration is not effective in reducing pain after abdominal hysterectomy. Effective postoperative analgesia should aim to eliminate the visceral pain component.

Analgesia, Patient-Controlled↗

PubMed1987

Is pyloroplasty necessary in esophageal replacement by stomach? A prospective, randomized controlled trial.

A randomized, prospective, controlled trial compared the use of pyloroplasty (study group) with nonuse of the procedure (control group) in the treatment of 72 patients with carcinoma of the thoracic esophagus. In these patients, transthoracic esophagectomy was performed, and the whole stomach was used for reconstruction in the right side of the chest. No complications due to the pyloroplasty developed in any of the patients who underwent this procedure. Gastric emptying tests that were performed at the sixth postoperative month in 37 patients demonstrated a prolongation of emptying time in the control group (p less than 0.01). The patients' symptoms, however, did not correlate well with gastric emptying time. Follow-up assessment showed that a higher proportion of patients who did not undergo pyloroplasty suffered from symptoms of incomplete emptying while eating, but the difference was not statistically significant. Moreover, the proportion of patients who were free of postoperative symptoms gradually increased in both groups and reached 100% in the study group and 89% in the control group at 2 years. In the control group, two of the three patients with prolonged gastric emptying time complained of persistent regurgitation and distending discomfort after meals (18 and 24 months after surgery). They were the only two patients who might have benefited from a drainage procedure at the initial operation. Since there apparently were no reliable operative criteria by which to identify patients who might require drainage, and since the risk associated with pyloroplasty was negligible, it would seem reasonable to perform a pyloroplasty on every patient in whom the whole stomach was used for reconstruction after esophagectomy. This procedure would benefit the few patients who might manifest symptomatic gastric stasis.

Adult↗

PubMed2001

Are distinctive ethical principles required for cluster randomized controlled trials?

Cluster randomized trials are increasingly used in research into health care and health services. Ethics of individual patient randomized trials have been elucidated in a number of different codes, but less attention has been given to the ethical issues raised by cluster randomized trials. I assess the challenges raised by cluster randomized controlled trials by considering three questions: What are the essential elements of ethical medical research, particularly experiments on people? What are the features which distinguish cluster randomized controlled trials from ordinary RCTs? Do the distinctive features of cluster randomized trials entail new ethical principles, or careful application of existing principles? I conclude that cluster randomized controlled trials raise new issues on the nature and practice of informed consent, because of the levels at which consent can be sought, and for which it can be sought. In addition, careful consideration of the principles relating to the quality of the scientific design and analysis, balance of risk and benefit, liberty to leave a trial, early stopping of a trial and the power to exclude people from potential benefits is required.

Cluster Analysis↗

PubMed2007

Reporting adverse events in randomized controlled trials.

PURPOSE: How randomized controlled trial results are reported may minimize concerns and detection of adverse side effects. We aimed to describe the methods of reporting adverse events in these published trials. METHODS: Five frequently cited journals were investigated: Annals of Internal Medicine, British Medical Journal, JAMA, The Lancet, and the New England Journal of Medicine. For each journal, all randomized controlled trials conducted on the use of a medication were selected from January 2000 through June 2003. All issues of each journal were reviewed manually. Information retrieved included any mention of adverse events in the abstract, methods, results, or discussion section of the article; or inclusion of adverse events data in tables or figures. We also cataloged whether there was a separate subheading in the results section for reporting adverse events. Reports of trials that referred to methods described in a previous report were excluded. RESULTS: There were 521 eligible articles. Explicit mention of adverse events was in 328 (63%) of abstracts (range 47-66%), 380 (73%) of methods (range 51-81%), 464 (89%) of results (range 80-95%), and 250 (48%) of tables (range 31-49%). There was a separate subheading for adverse events in 240 (46%) (range 22-64%) of the eligible articles. CONCLUSION: There is variation among authors and journals as to the location of reporting adverse events and the means by which it is done. Authors and editors should include specific information on adverse events when reporting the results of randomized controlled trials. It would be ideal if there was more consistency among authors and journals as to how these adverse events are described.

Adverse Drug Reaction Reporting Systems↗

PubMed2005

Is thrombolytic therapy associated with increased mortality? Meta-analysis of randomized controlled trials.

BACKGROUND: Although thrombolytic therapy has shown substantial benefits in neural outcomes, concerns remain regarding the association between thrombolytic therapy and possible increased mortality. OBJECTIVE: To determine the mortality risk of certain thrombolytic agents that are a treatment option for acute ischemic stroke. DATA SOURCES, EXTRACTION, AND SYNTHESIS: Studies were identified using MEDLINE, the Cochrane Central Register of Controlled Trials, and the reference lists of the articles selected. Randomized placebo-controlled trials of thrombolytic agents for the treatment of acute ischemic stroke patients were eligible. Study quality was evaluated using a previously validated scale. Data were extracted in duplicate by two independent investigators. All-cause mortality during follow-up was the main outcome. Random effects models were used to pool the individual effects of trials. Several preplanned sensitivity and subgroup analyses were completed to explain the heterogeneity among trials. Odds ratios, absolute risk differences, and numbers needed to harm were calculated. RESULTS: Eleven placebo-controlled randomized trials of thrombolytic agents involving 3709 participants were included in the analysis. Thrombolytic therapy was associated with an insignificant increase in mortality (odds ratio, 1.07; 95% confidence interval, 0.8-1.39; P = .3). The treatment was associated with an absolute increased risk of mortality of 11 per 1000 persons (95% confidence interval, -24 to 48; P = .3), and the number needed to harm was 84 (the 95% confidence interval included 0). CONCLUSION: These findings suggest that thrombolytic therapy does not significantly increase all-cause mortality.

Brain Ischemia↗

PubMed1999

The ALBI trial: a randomized controlled trial comparing stavudine plus didanosine with zidovudine plus lamivudine and a regimen alternating both combinations in previously untreated patients infected with human immunodeficiency virus.

A total of 151 previously untreated patients infected with human immunodeficiency virus type 1 (HIV-1) with CD4 cell counts >/=200/microL and plasma HIV-1 RNA levels of 10,000-100,000 copies/mL were randomly assigned to 24 weeks of open-labeled stavudine plus didanosine (group 1), zidovudine plus lamivudine (group 2), or stavudine plus didanosine followed by zidovudine plus lamivudine (group 3). The mean decrease in HIV-1 RNA level was greater in group 1 (2.26 log10 copies/mL) than in groups 2 (1.26 log10 copies/mL) or 3 (1.58 log10 copies/mL; P<.0001). The mean increase in CD4 cell counts was greater in groups 1 (124 cells/microL) and 3 (118 cells/microL) than in group 2 (62 cells/microL; P=.02). All regimens were generally well tolerated. The combination of stavudine plus didanosine reduced plasma HIV-1 RNA concentrations and increased CD4 cell counts more effectively than did the combination of zidovudine plus lamivudine or the regimen alternating both combinations.

Adult↗