None listed
Conditions
Interventions
This group will be treated with their regular HAART therapy plus Aciclovir 800 mg PO BID, every day for 6 months.
Group name:ARM B Type of group
This group will be treated with their regular HAART therapy plus Aciclovir Placebo PO BID, every day for 6 months.
Sponsors
COMPREHENSIVE INTERNATIONAL PROGRAM OF RESEARCH ON AIDS - CIPRA,
Eligibility
Inclusion criteria
Inclusion criteria: Women who meet the following criteria may be part of the study: 1.> of 18 years old. 1.> of 18 years of age. 2. Documentation of HIV-1 infection through a rapid test or ELISA and Westem confirmatory blot. 3. Women who start HAART according to the Peruvian guidelines, at the time of the start of the study drug. 4. CD4 + cell count 3.5). 6. Candidates with reproductive potential must submit a urine test for negative pregnancy in screening and enrollment. 7 Candidates of female sex without reproductive potential can be chosen without requiring the use of a contraceptive method. 8. Not having planned to move from Metropolitan Area of Lima during their participation in the study. 9. Willingness and willingness to: a) Provide written informed consent. b) Participate in clinical evaluations. c) Take the study drugs. d) Follow the monitoring schedule. e) Kamofsky score> 70 during the medical examination of the screening.
Exclusion criteria
Exclusion criteria: Women who meet any of the following criteria will not be chosen to participate in the study: 1. Women who started HAART prior to the initiation of the study. 2. Have a history of adverse reaction to valaciclovir, acyclovir or famciclovir. 3. Do not wish to take acyclovir, valaciclovir, or famciclovir voluntarily unless prescribed by the study doctor. 4. Have a history of seizures. 5. Have kidney failure. 6. Therapy for serious medical illness within 14 days before entering the study. 7. Any opportunistic infection (OI) or neoplasm included as an indicator of AIDS, should be treated and should be stable 14 days before the start of study enrollment. 8. Bacterial STDs should be treated and stable for at least 14 days before enrolling in the study. 9. Any condition that could disqualify participation in the study. 10. Radiation therapy or systemic chemotherapy during the 45 days prior to the start of the study. 11. Any immunomodulator, HIV vaccine or any research therapy during the 30 days prior to study entry. 12. Active use or dependence on drugs or alcohol that may interfere with adherence to the study requirements. 13. Inability to swallow medications or vomiting problems. 14. Mandatory detention in a correctional facility, prison or jail for treatment of psychiatric or physical illness. ´ 15. High grade cervical dysplasia (HSIL), grade 2 or 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HIV viral load tests will be performed on plasma, cervical and vaginal samples. They will be analyzed by an RT-PCR amplification assay. Measure:Undetectable HIV viral load in plasma (<50 copies / ml) after 6 weeks of treatment. Timepoints:Plasma and cervical samples: Before starting the study and weekly until 6 weeks of treatment. Vaginal samples: Before starting the study and in weeks 0, 1 y 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:HIV viral load tests will be performed on plasma, cervical and vaginal samples. They will be analyzed by an RT-PCR amplification assay. Measure:Viral load of undetectable plasma HIV ( 200 copies / ml). Positivity of PCR for HIV in mucosa samples. Timepoints:Plasma and cervical samples: Before starting the study and weekly until 24 weeks of treatment. Vaginal mucosa samples: Before starting the study and in weeks 0, 1, 2, 20, 21, 22, 23 and 24. | — |
Countries
Peru
Outcome results
None listed