None listed
Conditions
Interventions
Group 1 Type of group
Patients will receive Aciclovir 400 mg PO twice a day for 6 months
Group name:Group 2 Type of group
Patients will receive placebo orally twice a day for 6 months.
Sponsors
DIVISION DE SIDA (DADIS) E.U.A,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Be enrolled or have been in the HPTN 039. 2) Be HIV positive during follow-up in the HPTN 039. 3) Not being on antiretroviral therapy for HIV. 4) Do not try to move out of the atheist (of the study) for the duration of your participation in the study. 5) Eager and able to provide informed consent in writing independently. 6) Undergo clinical evaluations. 7) Continue taking the study drug as indicated for the next six additional months. 8) Adhere to the study´s monitoring schedule. 9) Provide adequate location information.
Exclusion criteria
Exclusion criteria: 1) Known history of adverse reactions to acyclovir. 2) Plans to travel outside the study area for> 2 months. 3) Current use of antiretroviral therapy during the study (at the time of enrollment). 4) Pregnancy confirmed by pregnancy test in urine at the time delenrolameinto. 5) Have been positive at the time of enrollment in the HPTN 039, confirmed by the retrospective evaluation. 6) More than 60 days from when the sample was taken. 7) Positive diagnosis with antibodies to HIV in HPTN 039. 8) Planned or current use of famciclovir, valaciclovir or acyclovir.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HIV RNA using RT-PCR using Amplicor HIV-I Monitor 1.5 Assay (Roche) Measure:To assess the efficiency of acyclovir in reducing viral load of HIV Timepoints:Months 1, 5 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Subset of CD4 + and CD8 + lymphocytes of whole blood. 2) Clinical evaluation 3) Genital or anal hidsopado to rule out HSV-2 infection Measure:Levels of CD-4. Incidence and severity of reactivation of HSV-2 Timepoints:1) Subset of CD4 + and CD8 + lymphocytes of whole blood: Months 0, 1, 5 and 6 2) Clinical evaluation: When symptoms occur or during scheduled visits: months 1, 2, 3, 4, 5 and 6 3) Genital or anal occlusion to rule out HSV-2 infection: When symptoms occur or during scheduled visits: months 1, 2, 3, 4, 5 and 6 | — |
Countries
Peru, South Africa, United States, Zambia, Zimbabwe
Outcome results
None listed