Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)
- Conditions
- -B203 HIV disease resulting in other viral infectionsHIV disease resulting in other viral infectionsB203
- Registration Number
- PER-017-06
- Lead Sponsor
- COMPREHENSIVE INTERNATIONAL PROGRAM OF RESEARCH ON AIDS - CIPRA,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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 <200 cells / mm3 obtained within 30 days prior to the start of the study.
5. Documentation of being HIV-2 seropositive by Focus EIA (IR> 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Undetectable HIV viral load in plasma (<50 copies / ml) after 6 weeks of treatment.<br>Timepoints:Plasma and cervical samples: Before starting the study and weekly until 6 weeks of treatment.<br>Vaginal samples: Before starting the study and in weeks 0, 1 y 2.<br>
- Secondary Outcome Measures
Name Time Method <br>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.<br>Measure:Viral load of undetectable plasma HIV (<50 copies / ml) at 24 weeks after initiation of HAART. Time to reach undetectable levels of viral load (<50 copies / ml) in patients coinfected with HIV-1 / HSV-2. HIV viral load in plasma during blips (> 200 copies / ml). Positivity of PCR for HIV in mucosa samples.<br>Timepoints:Plasma and cervical samples: Before starting the study and weekly until 24 weeks of treatment.<br>Vaginal mucosa samples: Before starting the study and in weeks 0, 1, 2, 20, 21, 22, 23 and 24.<br>