Nduba V, Mwachari CW, Meier A, Park D, Cohen CR; International Conference on AIDS (15th : 2004 : Bangkok, Thailand).
Int Conf AIDS. 2004 Jul 11-16; 15: abstract no. B12139.
Kenya Medical Research Institute, Nairobi, Kenya
Background: Acute respiratory tract infection (RTI) is the most common presentation to outpatient clinics in HIV-1 infected and uninfected adults in sub-Saharan Africa, with antibiotics prescribed for 50% to 90% of cases. We performed a randomized placebo controlled trial to determine whether treatment with amoxicillin vs. placebo produced equivalent cure rates in an adult population with a high HIV-1 seroprevalence presenting to an outpatient clinic in Nairobi. Methods: Adults with an acute productive cough 14 days were screened; those with evidence of chronic bronchitis, asthma, postnasal drip, sinusitis, penicillin allergy, clinical evidence of lung disease and abnormal chest X-ray were excluded. Those meeting eligibility criteria were tested for HIV-1. Enrolled participants were randomized to receive amoxicillin 500 mg thrice daily for seven days or a matched placebo, and returned for follow-up after 3, 7 and 14 days. A scoring system that included clinical signs and symptoms, and laboratory findings was used at every visit to assess clinical severity; a 75% decline at two-weeks was the primary outcome. With a significance level of.05, 700 adults will provide 80% power to demonstrate equivalent cure rates in the two study arms. Results: Since January 2002, 2506 adults were screened and 587 (23%) were enrolled representing 84% of the total sample size. Among those enrolled, the average age was 30 (SD 9), and 353 (60%) were female. Overall, 128 (22%) were HIV-1 seropositive: 94 of 353 (27%) of women and 34 of 234 (15%) of men (p=.001). Recruitment and follow-up will continue through March 2004, with final analysis available by June 2004. Conclusion: As the first randomized placebo controlled trial of acute bronchitis in Africa and the first to include HIV-1 infected individuals, findings from this investigation will guide development of outpatient treatment guidelines for RTI in similar populations with high HIV-1 seroprevalence.
Publication Types:
Keywords:
- Acute Disease
- Adult
- Africa
- Africa South of the Sahara
- Amoxicillin
- Anti-Bacterial Agents
- Blindness
- Bronchitis
- Case-Control Studies
- Clinical Trials as Topic
- Double-Blind Method
- Drug Therapy, Combination
- Female
- HIV Seropositivity
- HIV-1
- Humans
- Kenya
- Male
- Penicillins
- Placebos
- Respiratory Tract Infections
- Seroepidemiologic Studies
- Sinusitis
- drug therapy
- therapy
Other ID:
UI: 102276862
From Meeting Abstracts